Zdrowie i gospodarka · 3.04.2000
Dietary Supplements Containing Ephedrine Alkaloids; Withdrawal in Part
The Food and Drug Administration (FDA) is announcing that it is withdrawing certain provisions of a proposed rule that published in the Federal Register of June 4, 1997 (62 FR 30678), relating to dietary supplements containing ephedrine alkaloids. FDA is taking this action because of concerns regarding the agency's basis for proposing a certain dietary ingredient level and a duration of use limit for these products. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of new adverse event reports and related information associated with these products and its plans to participate in a public forum to discuss this new information at some future date. In addition, FDA is announcing elsewhere in this issue of the Federal Register the availability of additional documentation associated with certain adverse events referenced in the 1997 proposed rule.